Phase II Study of Low-Dose Radiotherapy Combined With Anti-PD-1 Immunotherapy Before Surgery for Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are investigating a new treatment for patients with locally advanced head and neck squamous cell carcinoma HNSCC, a condition where more than 60% of patients are diagnosed at an advanced stage. Despite current standard treatments such as surgery and chemoradiotherapy, many patients experience local recurrence within two years. This trial aims to evaluate a neoadjuvant approach combining low-dose radiotherapy with an anti-PD-1 immunotherapy to improve long-term survival based on encouraging evidence that low-dose radiotherapy can enhance immune response alongside immunotherapy. Participants will receive two cycles of neoadjuvant treatment consisting of low-dose radiotherapy 1 Gy per fraction on Days 1, 8, and 15 combined with the anti-PD-1 monoclonal antibody Toripalimab 240 mg on Day 1 every 3 weeks. Surgical resection follows 3-4 weeks after neoadjuvant therapy. After surgery, patients receive adjuvant treatments including radiotherapy dose depending on risk group and possibly cisplatin chemotherapy for high-risk patients. The study is a single-arm Phase II clinical trial led by Xiwei XU. During the study, participants will be closely monitored through pathological assessments one week post-surgery to measure treatment response and tumor remission. Researchers will track progression-free survival, overall survival, quality of life, and adverse events over one to two years. The total duration includes neoadjuvant therapy, surgery, adjuvant treatments, and long-term follow-up to evaluate safety and effectiveness of the combined regimen.

Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma